In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Kanesten Drug Master File in Korea (Kanesten KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Kanesten. The MFDS reviews the Kanesten KDMF as part of the drug registration process and uses the information provided in the Kanesten KDMF to evaluate the safety and efficacy of the drug.
After submitting a Kanesten KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Kanesten API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Kanesten suppliers with KDMF on PharmaCompass.